- Protocol Development: Ensure appropriate imaging strategy (collect-and-hold versus full analysis) applied to study; author imaging sections of protocol; conduct periodic review of standardized protocol language to ensure alignment with current practices and literature; facilitate review of imaging charter, site manual, and communication plan
- Vendor Engagement: Partner with Procurement and Alliance Management to perform vendor feasibility (RFI); partner with imaging vendors to standardize documentation, processes, and software applications to ensure consistency across the DS oncology portfolio.
- Quality Monitoring: Screen and select Independent Radiology and Oncology physicians (readers) for assignment to studies based on indication specific BICR experience; regularly monitor reviewer metrics for quality control in support of clinical trial endpoint data, and collaborate with Imaging CRO on remediation efforts to ensure independent reviewer calibration; maintain database of readers for assignment to similar studies/indications
- Cross-Functional Collaboration: Collaborate with clinical team and/or statistical team to perform routine review of BICR data to ensure expectations are met with respect to data points being collected and appropriate response assessment outcomes; foster relationships with Operations Leads to identify efficiencies in processes related to scan submission to vendors and communication pathways to ensure deliverables and timelines are met.
- Scientific Engagement: Develop BICR read processes (e.g., eligibility, verification of disease progression) and edit checks for incoming response assessment data to identify errors programmatically; Investigate trends in site/central discordance in response assessments.
- Promote Functional Excellence: Design workflows, identify dependencies, milestones in the conduct of imaging portion of study within internal teams and vendors; perform Lunch and Learn trainings on BICR processes; solicit feedback from stakeholders within the organization to identify pain points, gaps, or opportunities for improvements.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications: (from an accredited college or university)- Master's Degree required and
- PhD preferred or
- MD preferred Experience Qualifications
- 10 or More Years At least 15 years in Clinical Research in combined pharmaceutical company and Contracted Research Organization (CRO) environment required and
- 4 or More Years More than 5 years of experience in imaging operations in oncology clinical development of both early and late phase clinical trials, including development and review of imaging section of the protocol, imaging charter, site manuals, and communication plan
• Deep knowledge of implementation of oncology tumor assessment performed by (1) investigator/site and (2) BICR for both solid tumors and hematological malignancy.
- Extensive experience in BICR reader selection and performance monitoring and improvement
• Deep understanding of collection and QA of imaging and related non-imaging data from sites to Imaging Vendor to Sponsor
• Clear comprehension of computation and programming of BICR output (e.g., ORR, PFS, DoR) Familiar with good documentation practices and record retention processes, particularly those used in Biostatistics and Data Management groups.
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
- Master's Degree required and
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Director, Imaging Science Oversight - Basking Ridge, United States - Daiichi Sankyo
Description
Join a Legacy of Innovation 110 Years and Counting
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The Director of Oncology Imaging Science and Oversight will be a member of the Functional Excellence Team in Global Oncology Development, working with cross-functional stakeholders to develop and execute the imaging strategy for early and late phase study protocols with imaging-based endpoints. The Director will be a main point of contact for the processes associated with Blinded Independent Central Review (BICR) vendors.
Responsibilities:
